Ensure all cGMPs, validation, quality, safety and environmental regulations are met. Adhere to all GSK safety guidelines and procedures.
• Perform technical review of cGMP documentation and Batch Records for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
• Provide advice and counsel on cGMP and related quality assurance issues to the value stream.
• Demonstrate sound decision making relating to quality issues.
• Provide on the floor QA support and perform QA Operations activities.
• Take initiative to resolve quality documentation concerns.
• Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes.
• React to and escalate production issues.
• Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
• Write and/or revise controlled documents in support of job responsibilities.
1. Minimum Level of Education*
• BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
QA experience preferred. Minimum 1 year also preferred.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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